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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

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Nov 21

Understanding UDI in EU Device Regulations

Nov 25

FDA 483s, Warning Letters & Enforcement Trends

Nov 26

Increase Compliance, Reduce Risk with Integrated Digital Solutions: Create a Connected System and...

Dec 2

Understanding the Drug Supply Chain Security Act: Latest Regulatory Developments and Best Practices

Dec 5

Easily Own Your Safety Solution and Gain Control and Visibility

Dec 9

The Future of Generic Drug Competition: Deconstructing FDA and Congressional Initiatives

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California Diagnostics Maker Cited for Adulterated Devices

The agency found a lack of evidence that customers used the devices solely for forensic and R&D purposes, as required by their instructions for use.
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Glenmark’s Abiraterone Acetate Tablets Approved

The approval brings Glenmark’s portfolio to 162 products authorized for distribution in the U.S., with 46 ANDA’s pending approval, the company said.

GENVEC HALTS ENROLLMENT IN TRIAL FOR HEART DRUG

KEYWORDS Drug Pipeline Alert
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GenVec will stop enrolling patients in a Phase II trial testing the company's drug for treating severe coronary artery disease. The company will focus on its cancer-drug development instead, it announced.

Patients already enrolled in the Phase II study of the heart drug, called BioBypass, will complete follow-up and data will be collected and analyzed in accordance with the research agreement between GenVec and its collaborator, Cordis.